Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Inavolisib

Published On 2023-12-12 12:30 GMT | Update On 2023-12-12 18:40 GMT

New Delhi: The drug major Roche has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the trial of anti-cancer drug Inavolisib.

This came the drug major Roche presented Phase III Clinical Study Protocol no. WO44263. The study is to evaluate the efficacy and safety of Inavolisib in combination with Phesgo versus placebo in combination with Phesgo in participants with PIK3CA-Mutated HER2-Positive locally advanced or metastatic breast cancer.

Inavolisib is an oral therapy with high in vitro potency and selectivity for PI3Kα inhibition and the ability to specifically trigger the breakdown of mutant PI3Kα protein. With this unique dual mechanism of action, inavolisib may provide well-tolerated, durable disease control and potentially improved outcomes for people with HR-positive/HER2-negative, PIK3CA-mutated advanced breast cancer. PIK3CA mutations can lead to mutated PI3Kα protein which contributes to uncontrolled tumor growth, disease progression, and resistance to endocrine-based treatment.

Inavolisib is currently being investigated in three Phase III clinical studies in people with PIK3CA-mutated metastatic breast cancer (INAVO120, INAVO121, INAVO122) in various combinations.

At the recent SEC meeting for Oncology and Hematology held on 29th and 30th November 2023, the expert panel reviewed the Phase III clinical study protocol of the anti-cancer drug Inavolisib presented by drug major Roche.

After detailed deliberation, the committee recommended a grant of permission to conduct the trial as presented by the firm.

Also Read: Akum Pharmaceutical Gets CDSCO Panel Nod to Manufacture, Market Azelnidipine, Metoprolol FDC tablet

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Dr. Divya Colin

Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

Comments Policy

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Roche Gets CDSCO Panel Nod to Study anti-cancer Drug Inavolisib

Similar News

After Cough Syrup Deaths, CDSCO Tightens Oversight on Drug Testing Compliance

Exemed Pharma's Empagliflozin-Vildagliptin Combo Rejected by CDSCO Panel Over Questionable Clinical Use

Ravenbhel Gets SEC Nod to Market Bilastine, Montelukast FDC, Phase IV Trial Mandated

Drugs Control Officials Caught Taking Rs 20,000 Bribe in Telangana

Contaminated Cough Syrup horror: Centre proposes license cancellation of Coldrif maker, Tamil Nadu FDA yet to act

Himachal, UP Join States Banning Coldrif Cough Syrup After MP Deaths

Toxic syrup tragedy: MP police hunt pharma co owner after child deaths

Not of Standard Quality: Gujarat orders suspension of production at two pharma cos